RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
Report
- Report Number
- 9610773-2023-03288
- Event Type
- Malfunction
- Date Received
- November 14, 2023
- Date of Event
- October 26, 2023
- Report Date
- July 2, 2024
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HIH
- UDI-DI
- 04042761023658
- PMA / PMN Number
- K931994
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
G3: K931994/ K931995. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION AND THE CUSTOMER¿S REPORTED ISSUE WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE SEALING RING WAS DISCOLORED AND THE TIP WAS DAMAGED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, (SALES) SERVICE BUSINESS CENTER DID CONFIRM THE CERAMIC TIP ON THE INNER SHAFT WAS BROKEN. DURING THEIR INSPECTION, THEY ALSO DISCOVERED THE SEALING RING ON THE SHAFT WAS DISCOLORED. BASED ON THE DAMAGE PATTERN, IT WAS ASSUMED THAT THE DAMAGE TO THE INSULATION INSERT WAS INDUCED THERMALLY AND/OR MECHANICALLY. THEREFORE, IT WAS MOST LIKELY ATTRIBUTABLE TO WEAR AND TEAR AND/OR IMPROPER HANDLING BY THE CUSTOMER (MORE SPECIFICALLY THE DEVICE BEING SUBJECTED TO MECHANICAL OVERLOAD, IMPACT, ACCIDENTAL DROPPING, ETC.). IT CANNOT BE DETERMINED IF THERE WAS PRE-EXISTING DAMAGE TO THE INSULATION INSERT OR IF IT WAS ALREADY WORN. FURTHERMORE, IT CANNOT BE DETERMINED IF THE DAMAGE WAS CAUSED DURING THE LAST REPROCESSING OF THE INSTRUMENT OR DURING ITS LAST USE IN A PROCEDURE. AS A GENERAL NOTE, CRACKS ON THE INSULATION MATERIAL ARE MOSTLY NOT VISIBLE, MAKING VISUAL INSPECTION DIFFICULT. LOST FRAGMENTS OF THE CERAMIC INSULATION INSERT CAN BE LOCALIZED AND REMOVED USING A SUITABLE X-RAY PROCEDURE OR COMPUTED TOMOGRAPHY. ADDITIONALLY THE SEALING RING EVENT WAS LIKELY DUE TO WEAR AND TEAR FROM FREQUENT USE AND LACK OF MAINTENANCE. A DAMAGED SEALING RING IS VERY LIKELY TO LEAD TO LEAKAGE ON THE INNER SHAFT. THE EVENT CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING IFU. ¿4 BEFORE USE: WARNING INFECTION CONTROL RISK PROPERLY REPROCESS THE PRODUCT BEFORE FIRST AND EACH SUBSEQUENT USE FOLLOWING THE INSTRUCTIONS IN THIS MANUAL AND IN THE SYSTEM GUIDE ENDOSCOPY. IMPROPER AND/OR INCOMPLETE REPROCESSING CAN CAUSE INFECTION OF THE PATIENT AND/OR MEDICAL PERSONNEL. 4.1 INSPECTION AND TESTING INSPECTING THE PRODUCT VISUALLY INSPECT THE PRODUCT. MAKE SURE THAT IT HAS: -- NO CORROSION -- NO DENTS -- NO SCRATCHES CERAMIC INSULATION AT DISTAL END VISUALLY INSPECT THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END BEFORE EACH USE. DO NOT USE THE INSTRUMENT IN CASE OF DAMAGE (E.G. CRACKS, FRACTURES). WARNING RISK OF INJURY IMPACT, FALL, SHOCK OR SIMILAR STRESS CAN DAMAGE THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END. DAMAGED INSTRUMENTS CAN CAUSE INJURIES TO THE PATIENT AND/OR USER. DO NOT USE THE INSTRUMENT IF DAMAGED. DAMAGED PRODUCT IF THE PRODUCT IS DAMAGED OR DOES NOT FUNCTION PROPERLY, CONTACT AN OLYMPUS REPRESENTATIVE OR AN AUTHORIZED SERVICE CENTER.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION SHEATH HAD A BROKEN CERAMIC HEAD. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1990567 | RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS | HYSTEROSCOPE (AND ACCESSORIES) | HIH | OLYMPUS WINTER & IBE GMBH | A42011A | 101W-0006 | 04042761023658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |